BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9617032-2017-00004

    MDR report key: 6362174 · Received February 27, 2017

    Report

    Report Number
    9617032-2017-00004
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 23, 2017
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THIS INCIDENT IS UNKNOWN. HOWEVER, HE CUSTOMER PROVIDED THREE POTENTIAL LOT NUMBERS. THE INFORMATION FOR THESE LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6159908, MEDICAL DEVICE EXPIRATION DATE: 06/30/2018, DEVICE MANUFACTURE DATE: 06/07/2016. MEDICAL DEVICE LOT #: 6174876, MEDICAL DEVICE EXPIRATION DATE: 08/31/2018, DEVICE MANUFACTURE DATE: 06/22/2016. MEDICAL DEVICE LOT #: 6309534, MEDICAL DEVICE EXPIRATION DATE: 01/30/2018, DEVICE MANUFACTURE DATE: 11/04/2016. (B)(6). SIX UNUSED SAMPLES WERE RETURNED BY THE CUSTOMER (COVERING ALL 3 LOT NUMBERS) FOR EVALUATION. ALL UNITS WERE TESTED FOR SAFETY SHIELD DEFECTS. ALL ACTIVATED CORRECTLY, WITH NONE DETACHING. A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL THREE LOT NUMBERS REVEALED NO IRREGULARITIES DURING THE MANUFACTURING PROCESS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE THE CUSTOMER'S INDICATED FAILURE MODE. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT A POTENTIAL CAUSE FOR THIS DEFECT IS THAT LATERAL PRESSURE WAS PLACED ON THE SHIELD WHILE IT WAS BEING PUSHED INTO PLACE. THIS CAN HAVE THE EFFECT OF PUSHING THE SHIELD OUT OF THE PIVOT. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT FOR THE BD ECLIPSE¿ NEEDLE ATTACHED TO THE BD PRESET¿ SYRINGE. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-SA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE SUFFERED A CONTAMINATED NEEDLE STICK TO A FINGER ON HIS/HER LEFT HAND FROM A 3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP 22 G X 1 IN BD ECLIPSE¿ NEEDLE WHILE DISPOSING OF IT IN A SHARPS COLLECTOR. A PHYSICIAN IN THE O.R. HANDED IT TO THE NURSE AND IT IS UNKNOWN IF THE SAFETY MECHANISM WAS ACTIVATED. THE NURSE WAS EVALUATED BY OCCUPATIONAL HEALTH AND RECEIVED POST EXPOSURE LAB WORK FOR (B)(6). WHILE IT IS UNKNOWN IF THERE WAS AN ACTUAL SAFETY MECHANISM FAILURE, THE REPORTING FACILITY FELT THAT THE MOST PROBABLE CAUSE FOR THIS INCIDENT WAS THAT THE NEEDLE WAS NOT PROPERLY PROTECTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention